510(k) Report

Devices descending from K032922

7 later devices reach Clarissa Infant Ncpap Cannula through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250651OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS…Fisher & Paykel Healthcare, Ltd.20250—
+1K090935Minime Pediatric MaskSleepnet Corporation20095—
+2K121692Minime 2 Nasal MaskSleepnet Corporation20120—
+2K102224Pixi Pediatric MaskResmed, Ltd.20103—
+3K151683SleepWeaver Advance Pediatric Nasal CPAP MaskCircadiance, LLC20160—
+3K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company20121—
+4K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc.20240—